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    Summary
    EudraCT Number:2017-004210-25
    Sponsor's Protocol Code Number:MTI-106
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2017-004210-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis
    A.4.1Sponsor's protocol code numberMTI-106
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03677401
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMenlo Therapeutics Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMenlo Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMenlo Therapeutics Inc.
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address200 Cardinal Way, 2nd Floor
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post codeCA 94063
    B.5.3.4CountryUnited States
    B.5.6E-mailmspellman@menlotx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSerlopitant
    D.3.2Product code VPD-737
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSerlopitant
    D.3.9.1CAS number 860642-69-9
    D.3.9.2Current sponsor codeVPD-737
    D.3.9.3Other descriptive nameSERLOPITANT
    D.3.9.4EV Substance CodeSUB130838
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pruritus in adults with prurigo nodularis (PN)
    E.1.1.1Medical condition in easily understood language
    Pruritus
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037087
    E.1.2Term Pruritus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The efficacy objective of this study is to assess the efficacy of serlopitant for the treatment of pruritus in adults with prurigo nodularis.
    The safety objective is to assess the safety and tolerability of repeated oral doses of serlopitant in adults with prurigo nodularis.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age 18 years or older at consent.
    2. A diagnosis of PN, defined by the presence of at least ten pruriginous nodules secondary to chronic pruritus present on at least two different body surface areas (e.g. both arms, one arm and one leg, one arm and the anterior trunk, or anterior and posterior trunk).
    3. The worst pruritus is identified to be within the areas of the PN lesions.
    4. Subject has idiopathic PN OR the subject has an identified pruritic condition associated with the PN and has persistent pruritus despite at least 6 weeks of optimized and stable treatment of the underlying condition prior to the Baseline visit, and is willing to continue the treatment during the study. Please refer to Section 5.7.1.
    5. WI-NRS score ≥ 7 in the 24-hour period prior to the Screening visit.
    6. Average weekly WI-NRS score ≥ 6.5 in each of the 2 weeks (14 days) immediately prior to Baseline visit, as recorded in the eDiary.
    7. All female subjects who are of childbearing potential must be willing to practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of < 1% per year) from the time of the Screening visit until 5 weeks after last dose of study drug. Please refer to Section 7.1.5 for acceptable methods of contraception.
    8. Willing and able (as demonstrated by a ≥ 70% eDiary completion rate in the two weeks prior to Baseline visit) to complete daily eDiary entries within a consistent timeframe for the duration of the study.
    9. Willing and able (has adequate cognitive ability, in the investigator’s opinion) to comply with study visits and study related requirements including providing written informed consent.
    E.4Principal exclusion criteria
    1. Prior treatment with serlopitant.
    2. Active pruritic skin disease, other than PN, within 6 months prior to randomization (with the exception of acute dermatoses such as contact dermatitis, sunburn, viral exanthem, which have been resolved for longer than 4 weeks).
    3. Treatment with any of the following therapies within 4 weeks prior to randomization.
    a. Other NK1-R antagonists (e.g., aprepitant, fosaprepitant, rolapitant).
    b. Systemic or topical immunosuppressive/immunomodulatory therapies (including but not limited to systemic corticosteroids, phosphodiesterase-4 (PDE-4) inhibitors, cyclosporine, mycophenolate-mofetil, tacrolimus, pimecrolimus, calcipotriene, methotrexate, azathioprine, interferon-gamma, thalidomide, or phototherapy).
    c. Systemic therapies with recognized anti-pruritic properties (including but not limited to H1 antihistamines, doxepin, gabapentin, pregabalin, cannabinoids, kappa-opioid receptor agonists, and mu-opioid receptor antagonists (e.g. naloxone, naltrexone)).
    d. Strong CYP3A4 inhibitors
    e. Use of an indoor tanning facility, or natural sun exposure resulting in significant tanning or sunburn.
    4. Treatment with topical anti-pruritic therapies (e.g., menthol, camphor, pramoxine, capsaicin) within 2 weeks prior to randomization
    5. Treatment with biologic therapies within 8 weeks or 5 half-lives prior to randomization, whichever is longer.
    6. Treatment with any investigational therapy within 4 weeks (8 weeks for investigational biologic therapies) or 5 half-lives prior to randomization, whichever is longer.
    7. Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN) during screening.
    8. Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy.
    9. History of malignancy within 5 years prior to randomization, with the exception of actinic keratosis, completely treated and non-metastatic cutaneous basal cell carcinoma or squamous cell carcinoma of the skin.
    10. Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual
    disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to randomization.
    11. Suicidal ideation within 3 years prior to randomization, or any history of suicide attempt.
    12. Documented history of parasitic infection, including skin parasites such as scabies, within 8 weeks prior to randomization.
    13. Presence of any medical condition or disability that, in the investigator’s opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
    14. History of hypersensitivity to serlopitant or any of its components.
    15. Currently pregnant or breastfeeding female subject.
    16. Planned or anticipated major surgical procedure or other activity that would interfere with the subject’s ability to comply with protocol-mandated assessments (e.g. extended international travel) during the subject’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the Worst-Itch Numeric Rating Scale (WI-NRS) 4-point responder rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 10
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints are as follows:
    • WI-NRS 4-point responder rate at Week 4
    • Change from baseline in Dermatology Life Quality Index (DLQI) to Week 10

    Additional secondary efficacy endpoints are as follows:
    • Change from baseline in WI-NRS to other timepoints
    • WI-NRS 4-point responder rate at Week 2
    • WI-NRS 3-point responder rate at Weeks 2, 4 and 10
    • Change from baseline in Investigator’s Global Assessment of PN Activity (IGA PN-A) to Weeks 2, 4 and 10
    • Change from baseline in Investigator’s Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4 and 10
    E.5.2.1Timepoint(s) of evaluation of this end point
    please see section E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study, treatment of subjects with pruritus will be left to the discretion of their treating physicians based on local treatment guidelines.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-06
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